Balloon dissector with balloon tip cannula

ABSTRACT

There are disclosed various embodiments of a combined balloon dissector with balloon tip cannula which are provided to facilitate forming an anatomical space within the body, such as, for example, an anatomical space in the abdominal cavity or extraperitoneal space for facilitating hernia repair surgeries. The combined balloon dissectors with cannula generally include a cannula assembly for anchoring the device to the abdominal wall and a dissector assembly having a dissection balloon at a distal end for separating tissue layers and forming an anatomical space. Various combinations of valve ports and sub-assemblies are disclosed for providing inflation fluid to the balloon tip cannula, and inflation fluid for the dissection balloon.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of U.S. Provisional Application Ser.No. 60/468,919, filed May 8, 2003, and U.S. patent application Ser. No.10/680,368, filed Oct. 6, 2003, the disclosures of which are herebyincorporated by reference.

BACKGROUND

1. Technical Field

The technical field relates to balloon dissectors for forming ananatomical space within a body, to cannulas having balloon anchors, andto apparatus having a combined balloon dissector and balloon tipcannula.

2. Background of Related Art

During various surgeries, it is necessary to dissect tissue layers toform an anatomical space within which surgical instruments may bemanipulated. For example, in hernia repair surgery, it is necessary toform an anatomical operative cavity within the extraperitoneal space inorder to dissect fascia tissue layers and access the hernia site.Various balloon dissectors are known for performing the tissuedissection procedure used in hernia repair surgery. These generallyinclude a single device having a dissection balloon formed on the distalend of a tube and an inflation port formed on the proximal end of thetube. The balloon dissector is inserted into an incision and the balloonis inflated for dissection. After dissection and after removing theballoon dissector from the incision, a cannula is inserted into theincision and used to insufflate while forming an access passageway forthe introduction of surgical instruments into the anatomical space.

While the currently known tissue dissection devices and cannulas areuseful, improvements are desirable. It would be beneficial to have aballoon dissector device combined with a balloon tip cannula.

SUMMARY

There is disclosed a balloon dissector assembly for creating ananatomical space within a body and a balloon tip cannula assembly forproviding an access port into the body. The balloon dissector assemblyand the balloon tip cannula assembly can be used separately as standalone instruments or, preferably, as a combined balloon dissector andballoon tip cannula. Notably components on both devices allow them to beeasily combined.

In an aspect of the present invention, a balloon dissector and balloontip cannula assembly comprises: a balloon dissector including adissector tube defining a passage and a dissection balloon having aninterior and being affixed to a distal end of the dissector tube so thatthe passage and the interior communicate with one another; an obturatorconfigured for insertion through the passage; a balloon tip cannulahaving a cannula tube receiving the balloon dissector, the cannula tubehaving a distal end and an anchoring balloon at the distal end; and anadapter having a dissection inflation port in communication with thepassage for inflating the dissection balloon, an anchor inflation portin communication with the anchoring balloon, and an insufflation port incommunication with the cannula tube.

In a further aspect of the present invention, a balloon dissector andballoon tip cannula assembly comprises: a balloon dissector including adissector tube defining a passage and a dissection balloon having aninterior and being affixed to a distal end of the dissector tube so thatthe passage and the interior communicate with one another; an obturatorconfigured for insertion through the passage and into the interior ofthe dissection balloon; and a balloon tip cannula having a cannula tubereceiving the balloon dissector, the cannula tube having a distal endand an anchoring balloon at the distal end.

In certain preferred embodiments, the balloon dissector has an inflationport arranged for providing inflation fluid to the passage. The balloondissector may include latching structure to releasably retain theballoon tip cannula. Additionally or in the alternative, the balloon tipcannula may include latching structure to releasably retain the balloondissector.

In certain embodiments, the balloon dissector has a removable shroudarranged to cooperate with the latching structure on the balloon tipcannula. In certain preferred embodiments, an inner surface of thedissector tube and an outer surface of the obturator defines aninflation lumen therebetween for inflating the dissection balloon. Theballoon dissector may also include a dissector inflation valve so thatthe inflation lumen communicates between the dissector inflation valveand the dissection balloon.

In certain preferred embodiments, the assembly includes a separablesecuring sleeve arranged to retain the dissection balloon in an initialcollapsed configuration.

In a further aspect of the present invention, a balloon dissectorassembly, comprises: a balloon dissector including a dissector tubedefining a passage and a dissection balloon having an interior and beingaffixed to a distal end of the dissector tube so that the passage andthe interior communicate with one another; and an obturator configuredfor insertion through the passage and being arranged with the dissectortube so as to form an inflation lumen communicating with the interior ofthe balloon.

In a further aspect of the present invention, a balloon dissectorassembly comprises: a balloon dissector including a dissector tubedefining a passage and a dissection balloon having an interior and beingaffixed to a distal end of the dissector tube so that the passage andthe interior communicate with one another and so that the dissectionballoon extends from the distal end of the dissector tube; and anobturator configured for insertion through the passage and into theinterior of the dissection balloon so that the dissection balloon issupported on the obturator.

In certain preferred embodiments, the assembly includes a separablesecuring sleeve arranged to retain the dissection balloon in an initialcollapsed configuration on the obturator. The balloon dissector may alsohave an inflation port arranged for providing inflation fluid to thepassage. The inflation fluid is desirably communicated to the dissectionballoon. As the balloon starts to expand, a weakened region of thesleeve separates to release the dissection balloon. The expandeddissection balloon preferably forces tissue layers apart along naturaltissue planes to create an anatomical space.

In certain preferred embodiments, an inner surface of the dissector tubeand an outer surface of the obturator defines an inflation lumentherebetween. A proximal end of the balloon dissector desirably includesan orifice in communication with the passage so that upon removal of theobturator from the dissector tube, the dissection balloon deflates. Theballoon dissector desirably includes a dissector inflation valve and theinflation lumen communicates between the dissector inflation valve andthe dissection balloon.

In a further aspect of the present invention, a method of creating ananatomical space within a body for use in surgery comprises forming anincision in the body and inserting a balloon dissector assembly throughthe incision to a desired position. The balloon dissector assemblycomprises: i) a balloon dissector including a dissector tube defining apassage and a dissection balloon having an interior and being affixed toa distal end of the dissector tube so that the passage and the interiorcommunicate with one another; and ii) an obturator configured forinsertion through the passage and being arranged with the dissector tubeso as to form an inflation lumen communicating with the interior of theballoon. The method includes: inflating the dissection balloon byintroducing inflation fluid through the inflation lumen, so as to forcetissue layers apart along natural tissue planes to create an anatomicalspace; and deflating the balloon.

In a further aspect of the present invention, a method of creating ananatomical space within a body for use in surgery comprises forming anincision in the body and inserting a balloon dissector assembly throughthe incision to a desired position. The balloon dissector assemblycomprises: i) a balloon dissector including a dissector tube defining apassage and a dissection balloon having an interior and being affixed toa distal end of the dissector tube so that the passage and the interiorcommunicate with one another and so that the dissection balloon extendsfrom the distal end of the dissector tube; and ii) an obturatorconfigured for insertion through the passage and into the interior ofthe balloon so that the dissection balloon is supported on theobturator. The method includes the step of inserting including tunnelingthrough tissue with the obturator; inflating the dissection balloon soas to force tissue layers apart along natural tissue planes to create ananatomical space; and deflating the balloon.

In certain preferred embodiments, the obturator and dissector tubedefine an inflation lumen therebetween and the method includesintroducing inflation fluid into the inflation lumen so as to inflatethe dissection balloon. The method may include removing the obturatorbefore the step of inflating and inserting an instrument into thepassage. The instrument may comprise an endoscope.

In certain preferred embodiments, the obturator is removed after thestep of inflating so as to deflate the dissection balloon. The balloondissection assembly may include a separable securing sleeve arranged toretain the dissection balloon in an initial collapsed configuration andthe step of inflating the dissection balloon may include separating thesleeve.

In certain preferred embodiments, the balloon dissector assembly isinserted into the abdomen and a hernia in the abdomen is repaired.

In another aspect of the present invention, an assembly for providingsubcutaneous access to a body cavity comprises: a balloon tip cannulahaving a cannula tube and an anchoring balloon on a distal end of thecannula tube, the balloon tip cannula having an anchor inflation portand a lumen in communication with the anchoring balloon, the balloon tipcannula having an insufflation port for providing insufflation fluid tothe body cavity; an obturator received in the cannula tube; the balloontip cannula having an adapter on a proximal end thereof, the adapter andthe obturator being arranged for connecting the obturator and theballoon tip cannula, the adapter having at least one seal disposedwithin the adapter and being arranged to attach to a device to bereceived in the cannula tube after the obturator is removed from thecannula tube.

There is disclosed a novel method of securing a balloon anchor to a tubewhich includes the steps of dipping a selective region of the tube in asuitable material, for example, urethane, and positioning the inflatableballoon anchor about the selective region. Thereafter, opposed ends ofthe inflatable balloon anchor may be subjected to a thermal weld to weldthe opposed ends to the coated selective region. There may beadditionally provided a silicone sleeve positionable over the inflatableballoon anchor and secured thereto by means of heat shrink rings appliedto opposed ends of the silicone sleeve.

In certain preferred embodiments, the cannula tube has a wall and alumen is defined in the wall, the lumen communicating with the anchorinflation port and the anchoring balloon. A skin seal may be movablymounted on the cannula tube. The skin seal may include structure forsecuring the skin seal at a desired longitudinal location on theelongated tube.

In certain preferred embodiments, the at least one seal includes a firstseal for sealing the cannula tube in the absence of an instrument beingreceived within the cannula tube. The at least one seal may also includea second seal for sealing the cannula tube when the instrument isreceived within the cannula tube. The insufflation port is preferablylocated distally of the at least one seal.

In certain preferred embodiments, the device comprises the obturator andin others, the device comprises a dissector.

The obturator may include an elongate body configured to fit within thecannula tube so as to extend partially out the distal end of the cannulatube.

In another aspect of the present invention, a method of creating ananatomical space within an abdomen and providing subcutaneous access toa body cavity within the abdomen comprises: creating the anatomicalspace using a dissector inserted into an incision in the body, thedissector being connected to a balloon tip cannula; inserting theballoon tip cannula through the incision, the balloon tip cannulacomprising a cannula tube with an anchoring balloon on a distal endthereof and an adapter on a proximal end thereof, the adapter beingarranged for connecting with the dissector; detaching the balloon tipcannula from the dissector; inflating the anchoring balloon; engagingthe anchoring balloon against an inner surface of the body cavity;sliding the skin seal distally against an outer surface of the bodycavity; and removing the dissector and introducing insufflation fluidinto the body cavity. Desirably, the step of detaching is performedbefore the step of inserting the balloon tip cannula and the balloon tipcannula is advanced distally on the dissector. The method may includeremoving an obturator from the balloon tip cannula and the dissector maybe inserted in the balloon tip cannula.

The skin seal may be secured in place. An endoscope may be inserted intothe balloon tip cannula after the step of removing the dissector. Theballoon tip cannula desirably includes an anchor inflation port incommunication with the anchoring balloon and the method may include thestep of deflating the anchoring balloon by opening the anchor inflationport. In a further aspect of the present invention, a method ofdissecting tissue and providing subcutaneous access to a body cavitycomprises introducing a balloon dissector and balloon tip cannulaassembly into an incision. The balloon dissector and balloon tip cannulaassembly comprises: i) a balloon dissector including a dissector tubedefining a passage and a dissection balloon having an interior and beingaffixed to a distal end of the dissector tube so that the passage andthe interior communicate with one another, the balloon dissector havingan inflation port arranged for providing inflation fluid to the passage;ii) a first obturator configured for insertion through the passage andinto the interior of the dissection balloon; and iii) a balloon tipcannula having a cannula tube and an anchoring balloon on a distal endof the cannula tube. The method includes: inserting the balloondissector and balloon tip cannula assembly into the body to a desiredlocation; inflating the dissection balloon so as to dissect tissue alongnatural tissue planes; deflating the dissection balloon; advancing adistal tip of the balloon tip cannula through the incision to positionthe anchoring balloon within the body cavity; inflating the anchoringballoon and advancing the skin seal against the outer surface of thebody; removing the balloon dissector and first obturator from theballoon tip cannula; and introducing insufflation fluid into the body.

In certain preferred embodiments, the balloon tip cannula has a secondobturator and the method includes the step of assembling the balloon tipcannula and balloon dissector by removing the second obturator andinserting the balloon dissector into the balloon tip cannula. Latchingstructure on the balloon dissector may be engaged with the balloon tipcannula. The first obturator is removed before the step of deflating andan endoscope is inserted into the dissector tube. The method may includereleasing the latching structure from the balloon tip cannula.

The skin seal is desirably secured against the outer surface of thebody. Desirably, the method includes deflating the anchoring balloon.The balloon tip cannula may be removed from the body.

BRIEF DESCRIPTION OF THE DRAWINGS

Preferred embodiments of the presently disclosed balloon dissector andballoon tip cannula are described herein with reference to the drawings,wherein:

FIG. 1 is a cross-sectional side view of a balloon dissector assemblyaccording to an embodiment of the present invention;

FIG. 2 is an exploded perspective view of the balloon dissector assemblyin accordance with the embodiment of FIG. 1;

FIG. 2A is a cross-sectional view taken along line 2A-2A in FIG. 1;

FIG. 2B is a perspective view of a balloon in accordance with theembodiment of FIGS. 1-2A.

FIG. 3 is a cross-sectional side view of a balloon tip cannula assemblyaccording to another embodiment of the present invention;

FIG. 4 is an exploded perspective view of the balloon tip cannulaassembly in accordance with the embodiment of FIG. 3;

FIG. 4A is a perspective view of the elongated tube of the balloon tipcannula and inflatable balloon anchor;

FIG. 4B is a perspective view of the elongated tube of the balloon tipcannula with the inflatable balloon anchor positioned over a distal end;

FIG. 4C is a view similar to that of FIG. 4B with opposed ends of theinflatable balloon anchor welded to the elongated tube;

FIG. 4D is a perspective view of a silicone sleeve and heat shrinktubing for securement over the inflatable balloon anchor;

FIG. 5 is a cross-sectional side view of a combined balloon dissectorwith balloon tip cannula according to a further embodiment of thepresent invention;

FIG. 6 is a perspective view of the combined balloon dissector withballoon tip cannula in accordance with the embodiment of FIG. 5;

FIG. 7 is a cross-sectional view of a further embodiment of a combinedballoon dissector and balloon tip cannula;

FIG. 8 is a perspective view of the combined balloon dissector andballoon tip cannula in accordance with the embodiment of FIG. 7;

FIG. 9 is a cross-sectional view of the balloon dissector in accordancewith the embodiment of FIG. 7; and

FIG. 10 is a cross-sectional view of the balloon tip cannula inaccordance with the embodiment of FIG. 7.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

Preferred embodiments of the presently disclosed balloon dissectorassembly, balloon tip cannula assembly and the combined balloondissector with balloon tip cannula will now be described in detail withreference to the drawings, in which like reference numerals designateidentical or corresponding elements in each of the several views. Asused herein, the term “distal” refers to that portion of theinstruments, or component thereof, which is further from the user whilethe term “proximal” refers to that portion of the instrument, orcomponent, thereof which is closer to the user.

Referring to FIGS. 1 and 2, a balloon dissector assembly 10 according toan embodiment of the present invention is shown. Balloon dissectorassembly 10 generally has a longitudinal axis-X and includes a balloondissector 12 having an adapter assembly 24 and an obturator assembly 26.Balloon dissector assembly 10 includes a dissection balloon 14configured and adapted for inflating in order to separate layers oftissue to form an anatomic space within the body of a patient. Aninflation aperture 16 is located in the proximal region of dissectionballoon 14 and is dimensioned to receive and be affixed to a distal endof a dissector tube 18. Dissector tube 18 is an elongated tubularstructure having open proximal and distal ends defining an accesspassage 20 therebetween. An inflation port 22 is located at a proximalend of dissector tube 18 and provides a communicative channel betweenthe passage 20 and a source of inflation pressure.

It is further envisioned that dissection balloon 14 may be manufacturedfrom a material wherein the distal region 58 includes a substantiallytransparent section, or window, thereby allowing visual access to thedissected space. Additionally or alternatively, dissection balloon 14may be manufactured from a material that is substantially transparent,also allowing visual access to the dissected space. As inflationpressure is applied, dissection balloon 14 desirably expands to apredetermined shape and size. Different shapes and sizes are envisionedwith the surgical procedure to be performed determining which shape andsize is selected. The dissection balloon can be elastic in alldirections, relatively inelastic, selectively elastic in a particulardirection such as in its height.

Referring for the moment to FIGS. 2A and 2B, a sleeve cover 60 isprovided around dissection balloon 14 to retain dissection balloon 14 ina collapsed condition during insertion into the body and prior toinflation. Sleeve cover 60 may be affixed to dissection balloon 14,attached to dissector tube 18 or movably mounted with respect thereto.Sleeve cover 60 includes a longitudinal weakened perforated region 21such that upon inflation of dissection balloon 14 the sleeve separatesalong the perforations and releases dissection balloon 14. In certainpreferred embodiments, the dissection balloon 14 has marginal ends 11and 13 that are rolled inwardly toward axis X and secured using thesleeve cover 60. The sleeve cover is heat sealed at 19 to the materialof the balloon in the form of two flaps 15, 17. After the marginal edges11 and 13 are folded or rolled, the flaps of the sleeve cover 60 areextended around the rolled balloon and the flaps are heat sealed to oneanother. Preformed perforation 21 in one of the flaps enables the sleevecover 60 to separate upon inflation of the balloon.

Prior art dissection balloons are generally disposed substantiallyorthogonal to the longitudinal axis of the device wherein their initialinflation motion aligns them with the longitudinal axis, possiblyincreasing unintended tissue damage. In the present embodiment, theballoon desirably unrolls or unfolds in a lateral direction.

An adapter assembly 24 is configured for attachment to the proximal endof dissector tube 18 and generally includes a shroud 28 and an end cap30 having a latching adaptor 34 attached to end cap 30, as best seen inFIG. 2. Located in a distal region of adapter assembly 24, the removableshroud 28 is dimensioned for surrounding the proximal end of dissectortube 18. Shroud 28 is preferably configured in a generallyfrusto-conical shape wherein a narrow portion surrounds dissector tube18 and a wider portion is adapted for receiving latching adapter 34.Latching adapter 34 includes a pair of opposed arms 36. Each arm 36 isgenerally flexible and biased to spring return to its starting position.Furthermore, each arm 36 includes a distal hook 38 and a proximal lever40. By actuating levers 40 towards longitudinal axis-X, arms 36 pivotabout an attachment point causing each hook 38 to rotate generally aboutits attachment point. When latching adapter 34 is attached to shroud 28,hooks 38 are in releasable engagement with recesses 41 formed in shroud28.

The distal end of latching adapter 34 includes a plurality of tabs 42and are configured for affixing latching adapter 34 to an inner wall 44of end cap 30, as best seen in FIG. 1. Inner wall 44 a of end cap 30surrounds and is affixed to a proximal end of dissector tube 18. Acentral opening through latching adapter 34 is provided to receivedifferent devices, such as, for example, an obturator or an endoscope,which can be received through the end cap 30, latching adaptor 34,shroud 28 and tube 18, and position these devices within balloon tipdissector assembly 10. In certain preferred embodiments, the centralopening is dimensioned for slidingly receiving devices generally havinga diameter of between about 5 and about 10 millimeters, althoughembodiments for accommodating smaller and larger sizes are contemplated.

The adapter assembly 24 may comprise one or more parts. In otherembodiments, any of the end cap 30, latching adapter 34, and shroud 28may be combined in a unitary part. Preferably, shroud 28 isergonomically designed for use by a surgeon and configured to give theballoon dissector a streamlined look. In a preferred embodiment, the endcap 30, latching adapter 34 and shroud 28 are combined in one integralpart attached to a proximal end of the dissector tube 18.

An adapter orifice 46 and a connecting port 48 are located on end cap30. Optimally, adapter orifice 46 is substantially circular, centrallylocated on end cap 30, and configured to receive devices therethrough. Adiameter reducing device (not shown) may be included as well toaccommodate devices having a diameter less than a given size. Thereducing device would be attached to end cap 30 over adapter orifice 46for engaging tubular surgical devices of differing sizes and providing adegree of stability for the surgical devices inserted through adapterorifice 46. Alternatively or additionally, the end cap 30 desirablyincludes a seal for maintaining fluid pressure within the dissectionballoon when the obturator or scope is received in the inflation tubeand through the end cap 30. The connecting port 48 is dimensioned forreceiving a valve 50 in a sealing manner such that valve 50 is in fluidcommunication with connecting port 48.

A dissector inflation valve 50 is preferably located on a surface of endcap 30 that is readily accessible during a surgical procedure. Whendissector inflation valve 50 is attached to end cap 30, valve port 52 isaligned and in fluid communication with inflation port 22 in dissectortube 18 and therefore in fluid communication with dissection balloon 14.Dissector inflation valve 50 also includes a valve handle 54 that isrotatably attached to dissector inflation valve 50 wherein internalvalve ports (not shown) are configured to permit fluid flow betweenvalve port 52 and inflation port 22.

In a preferred embodiment, dissector inflation valve 50 is a one-waycheck valve with a stopcock for inflating and deflating dissectorballoon 14. In use, inflation pressure is applied to valve port 52 thatis further communicated through the circumferential lumen of dissectortube 18 causing dissection balloon 14 to expand. Having a check-valveinternal to dissector inflation valve 50 minimizes the loss of inflationpressure through dissector inflation valve 50 thereby allowingdissection balloon 14 to maintain its shape and inflation pressure.Advantageously, dissector inflation valve 50 includes a stopcock forreleasing the inflation pressure. Including a stopcock with dissectorinflation valve 50 allows the surgical personnel to have better controlover the inflation and deflation of dissection balloon 14 since it isintegrated into dissector inflation valve 50, and valve 50 is readilyaccessible to the surgical personnel. In other embodiments, a separatedeflation device may be provided.

According to the present disclosure, obturator assembly 26 generallyincludes an obturator body 64 having a tip 66 that is generally conicalin shape and is formed the distal end of the obturator body 64. Locatedat the proximal end of obturator body 64 is an obturator flange 68. Anobturator cap 70 is affixed to obturator flange 68. Preferably,obturator cap 70 is ergonomically shaped for comfortable use by surgicalpersonnel. In certain preferred embodiments, the obturator comprises aunitary part having an elongated body and a proximal end desirablyergonomically shaped for use by surgical personnel.

To assemble the balloon dissector assembly 10 prior to use, tip 66 ofobturator assembly 26 is inserted through adapter orifice 46 andobturator assembly 26 is advanced distally along longitudinal axis-X.When the underside of obturator flange 68 abuts end cap 30, maximumlongitudinal travel of obturator assembly 26 is accomplished. Theobturator body 64 is sized so that the outer surface of obturator body64 and the inner surface of dissector tube 18 form an inflation lumen 23between valve port 52 and dissection balloon 14.

In order to inflate dissection balloon 14, a source of inflationpressure is releasably attached to valve port 52. Valve handle 54 isrotated to align the internal valve ports for fluid flow throughdissector inflation valve 50. Pressurized fluid is introduced throughvalve port 52 and is communicated through dissector inflation valve 50,inflation port 22, and inflation lumen 23 to dissection balloon 14. Inanother alternative, the dissector tube 18 terminates at a locationdistal of the valve 50 and connecting port 48 and the inflation port 22is eliminated. Examples of preferred inflation fluids include CO₂,saline solution, or other biocompatible fluids. The pressurized fluidcauses dissection balloon 14 to expand. In a preferred embodiment,dissection balloon 14 is manufactured from a suitable biocompatiblematerial. For example, the balloon may comprise a sheet having athickness of about 2 mils, or 0.002 inches.

A method of use for balloon dissector assembly 10 as a stand alonedevice is disclosed. Alternatively, balloon dissector assembly 10 can beused with an access port or cannula in the manner described hereinbelow. Balloon dissector assembly 10 is shown in an assembled state inFIG. 1. Typically, a suitably sized incision is made in the patient'sskin. Next, the assembled balloon dissector assembly 10 is inserted intothe incision using obturator 26 positioned within balloon dissector 12to tunnel a passage beyond the point of incision, with the dissectionballoon 14 supported on the obturator body 64. As balloon dissectorassembly 10 is inserted, dissection balloon 14 is restrained by sleevecover 60 and generally surrounds the distal region of obturator body 64that extends beyond the distal end of dissector tube 18. Preferably,dissection balloon 14 is formed from a material that has sufficientstrength to minimize damage to dissection balloon 14 during thetunneling process, but is also has a minimal surface resistance, therebypermitting ease of entrance of dissection balloon 14 into the incisionand the surrounding soft tissue.

Inflation pressure is applied through valve port 52 from a suitableoutside source and is communicated through dissector inflation valve 50to dissection balloon 14. As pressure is applied, dissection balloon 14expands and causes the perforated sleeve cover 60 to separate alongperforations 21, or a weakness in the sleeve cover 60 material to break,so as to release dissection balloon 14. Dissection balloon 14 unrolls orunfolds laterally and expands vertically to a predetermined shape andsize. The vertical expansion of dissection balloon dissects surroundingtissue along natural tissue planes. Once the desired space is created,dissection balloon 14 is deflated by operating the stopcock on valve 50to release the pressure inside dissection balloon 14. Alternately,removal of obturator assembly 26 allows the inflation pressure to berelieved through the opening at adapter orifice 46.

Following removal of obturator assembly 26, other suitable configuredsurgical instruments, or devices may be inserted into dissector tube 18.One such example is an endoscope for viewing the dissected space whereinat least a portion of the dissection balloon 14 is substantiallytransparent for viewing the dissected space. In alternative embodiments,the obturator assembly 26 may be removed, either before or after theballoon dissector assembly 10 is introduced into the body, and theendoscope may be inserted into the dissector tube 18 prior to inflationof the dissection balloon. Desirably, the balloon dissector assembly 10is removed after dissection and the dissected space is insufflated, asis known in the art.

Referring now to FIGS. 3 and 4, there is disclosed a balloon tip cannulaassembly 80 for use as an access port for use with various surgicalinstruments or in combination with balloon dissector assembly 10 asdescribed in more detail hereinbelow. A balloon tip cannula assembly 80generally includes a balloon tip cannula 82 having a seal assembly 84and an obturator 86.

Balloon tip cannula 82 comprises an elongated tube 88 that is open atits proximal and distal ends defining an access lumen 90 for receipt ofsurgical instruments therethrough. A proximal lumen port 92 and a distallumen port 94 are disposed on an outer surface of the cannula 88.Defined between the inner surface and the outer surface of tube 88 is aninflation lumen 96 extending along longitudinal axis-x and communicatingwith proximal and distal lumen ports 92, 94. An inflatable balloonanchor 98 is disposed in the distal region of tube 88. In a preferredembodiment, balloon anchor 98 has a generally toroidal shape, is locatedalong tube 88, and encloses distal lumen port 94 in a substantiallyfluid-tight sealing manner. Further still, balloon anchor 98 isexpandable to a predetermined size and shape.

Referring for the moment to FIGS. 4A to 4C, inflatable balloon anchor 98is affixed to a distal end of elongated tube 88 in a novel manner. Inorder to prepare elongated tube 88 to receive inflatable balloon anchor98, a selective region 150 of elongated tube 88 is dipped in a suitablematerial having characteristics sufficient for adhesion to inflatableballoon anchor 98. Preferably, selective region 150 is dipped in aurethane material to result in a urethane coating 152 over selectiveregion 150. In order to attach inflatable balloon anchor 98 to elongatedtube 88, inflatable balloon anchor 98 is initially positioned overselective region 150 and about distal lumen port 94. As best shown inFIG. 4C, opposed ends 154 and 156 of inflatable balloon anchor 98 aretreated to a thermal welding procedure to hot weld opposed ends 154 and156 to coating 152 on the distal end of elongated tube 88. In thismanner, inflatable balloon anchor 98 is securely affixed to selectiveregion 150 of elongated tube 88.

Referring to FIG. 4D, in a preferred embodiment, there is provided asilicone sleeve 158 which is configured to be positioned aboutinflatable balloon anchor 98. Silicone sleeve 158 is secured aboutinflatable balloon 98 by a pair of rings 160 and 162 which arepositioned about opposed ends 164 and 166 of silicone sleeve 158.Preferably, rings 160 and 162 are formed of a heat shrinkable materialsuch that when silicone sleeve 158 is positioned over inflatable balloonanchor 98 and heat shrink rings 160 and 162 are positioned about opposedends 164 and 166 of silicone sleeve 158, rings 160 and 162 may besubjected to a heat treatment which will shrink rings 160 and 162thereby securing silicone sleeve 158 over inflatable balloon anchor 98.The rings 160 and 162 serve to reinforce the balloon anchor 98 at itsproximal and distal ends. The sleeve 158 may comprise a sleeve of anyresilient, bio-compatible material. Furthermore, other methods may beused to attach the balloon anchor 98 to the tube 88, such as by adheringthe balloon anchor 98 to the tube 88. In further alternatives, theballoon anchor 98 may be suture-tied to the balloon and coated with RTV.

Referring to FIG. 4, in a preferred embodiment, balloon tip cannula 82further includes a skin seal 100 slidably attached to the outside oftube 88. Skin seal 100 desirably includes a foam collar 102 and asecuring means 104 for securing the skin in a desired longitudinalposition along longitudinal axis-x. A suitable skin seal is disclosed inInternational Publication No. WO02/096307 entitled Balloon Cannula withOver Center Clamp, the entire disclosure of which is hereby incorporatedby reference herein. When balloon tip cannula 82 is inserted through anincision in the patient's skin, skin seal 100 is moved into positionagainst the skin surface of the patient's body forming a pressurebarrier, thereby minimizing the loss of inflation pressure through theopening in the patient's skin, and in combination with anchor balloon98, secures balloon tip cannula 82 to the patient's body.

Balloon tip cannula 82 additionally includes an adapter flange 106having proximal and distal openings defining a bore therebetween. On onesurface of adapter flange 106 is a valve port 108 dimensioned to receivea valve 110 in a substantially fluid-tight sealing manner. The distalend of adapter flange 106 is dimensioned to receive and be affixed tothe proximal end of cannula tube 88 in a substantially fluid-tightsealing manner. When the proximal end of cannula tube 88 is fullyinserted in the distal end of adapter flange 106, valve port 108 isaligned with proximal lumen port 92, and thereby aligned with valve 110.Located near the proximal end of adapter flange 106 are a pair ofrecesses 112 each having a generally rectangular configuration andpreferably diametrically opposed to one another. Recesses 112 areconfigured to receive a latching structure associated with obturator 128as described hereinbelow. Alternatively, when used in combination withballoon dissector 12 as described hereinbelow, recesses 112 provideattachment points for latching adaptor 34. In other embodiments, nolatching structure is used between the balloon dissector assembly 10 andballoon tip cannula assembly 80.

Balloon tip cannula 80 preferably employs a one-way check valve having astopcock for inflating and deflating anchor 98. An anchor inflationvalve 110 is preferably located on a surface of adapter flange 106 thatis readily accessible during a surgical procedure. When anchor inflationvalve 110 is attached to adapter flange 106, valve port 114 is alignedand in fluid communication proximal lumen port 92 and therefore in fluidcommunication with balloon anchor 98. Anchor inflation valve 110 alsoincludes a valve handle 116 that is rotatably attached to anchorinflation valve 110 wherein internal valve ports (not shown) areconfigured to permit fluid flow between valve port 114 and proximallumen port 92. In other embodiments, a separate deflation device may beprovided.

In order to inflate balloon anchor 98, a source of inflation pressure isreleasably attached to valve port 114. Valve handle 116 is rotated toalign the internal valve ports for fluid flow through anchor inflationvalve 110. Pressurized fluid is introduced through valve port 114 and iscommunicated through anchor inflation valve 110, proximal lumen port 92,and inflation lumen 96 to balloon anchor 98. Examples of preferredinflation fluids include CO₂, saline solution, or other biocompatiblefluids. The pressurized fluid causes balloon anchor 98 to expand. In apreferred embodiment, anchor inflation valve 110 is a one-way checkvalve with a stopcock. Having a check-valve internal to anchor inflationvalve 110 minimizes the loss of inflation pressure through anchorinflation valve 110 thereby allowing balloon anchor 98 to maintain itsshape and inflation pressure. Advantageously, anchor inflation valve 110includes a stopcock for releasing the inflation pressure. Including astopcock with anchor inflation valve 110 allows the surgical personnelto have better control over the inflation and deflation of balloonanchor 98 since the stopcock is mounted on anchor inflation valve 110where it is readily accessible to the surgical personnel. However,separate inflation and deflation devices may be provided on the balloontip cannula.

An insufflation port 120 is provided on adapter flange 106 and in fluidcommunication with the interior of adaptor flange 106 and interior oftube 88 to provide insufflation fluid to the interior of a patient'sbody.

Seal assembly 84 generally includes a duckbill seal 122 configured andadapted to be received by the interior surface of adapter flange 106wherein the outer surface of duckbill seal 122 and the interior surfaceof adapter flange 106 mate in a substantially fluid-tight sealingmanner. Duckbill seal 122 functions in conventional manner to sealballoon tip cannula in the absence of an instrument having been insertedinto the balloon tip cannula, and provide a seal against the escape ofinsufflation fluid. While duckbill seal 122 is shown closed in FIG. 3with obturator 86 in place, it is to be understood that duckbill seal122 would only be closed in the absence of an instrument therethrough.An opening is located at the proximal end of duckbill seal 122 forreceiving an adapter ring 124. Adapter ring 124 is sized for snugengagement with duckbill seal 122 and includes a substantially centralorifice dimensioned to receive a surgical device, such as an obturatorand provides a seal around such surgical device. Further still, adapterring 124 is maintained in position within the proximal region ofduckbill seal 122 by a retainer ring 126 having a central openingsubstantially equal to the opening of adapter ring 124. A reducingdevice as described hereinabove with respect to balloon dissector 12 maybe included as well to accommodate various diameter instruments. Thereducing device is attached to retainer ring 126 for slidably engagingtubular surgical devices of differing sizes and providing a degree ofstability for the surgical devices inserted through retainer ring 126.Although the duckbill seal 122 and ring 124 are shown in thisembodiment, other embodiments include seals having differentconfigurations. Desirably, the balloon tip cannula assembly 80 includeboth a seal for sealing the interior of tube 88 in the absence ofinstruments that may be received in the assembly, as well as a seal forsealing against an instrument, once inserted into the assembly.

Balloon tip cannula assembly 80 further includes obturator 86 forfacilitating insertion of balloon tip cannula through an incision in apatient's body. Obturator 86 generally includes a obturator body 128, acap 130 affixed to obturator body 128 and a latching adapter 132 affixedto cap 130 and surrounding obturator body 128. In further embodiments,the latching adapter 132 is eliminated and latches are incorporated oncap 130. Obturator body 128 is generally elongate and cylindrical andhas a rounded obturator tip 134 located at the distal end of obturatorbody 128. Obturator body 128 includes an obturator adapter 136 disposedat its proximal end.

Latching adapter 132 is attached to cap 130 in a manner similar to thatdescribed above with respect to the latching adapter of balloondissector 12. Obturator adaptor 136 is affixed to an inner surface ofcap 130. Latching adapter 132 is generally circular in configurationhaving a throughbore. A plurality of resilient tabs 138 are located atthe distal end, each tab 138 being separated from each other tab by aslot. In addition, each tab 138 is biased towards the center of thethroughbore for engagement with cap 130 in a manner similar to thatdiscussed above with respect to latching adapter 34 and end cap 30.Located near the proximal end of latching adapter 132 is a pair ofdiametrically opposed arms 140. Each arm 140 is pivotably attached tolatching adapter 132 whereupon each arm 140 rotates about a pivot pointsubstantially perpendicular to longitudinal axis-x. Preferably, each arm140 is biased in a starting position, is capable of rotation away fromthe other arm, and includes a hook 142 at its distal end wherein eachhook 142 is configured to releasably mate with recess 112 of adapterflange 106.

When obturator 86 is inserted and advanced along longitudinal axis-xthrough retaining ring 126, adapter ring 124, duckbill seal 122, andthrough tube 88, latching adapter 132 is advanced distally and hooks 146approach and engage recesses 112. Preferably, the arms 140 are biasedtoward a latching position and deflect inwardly, then snap intoengagement with recesses 112. The operator may rotate arms 140 by movinglevers 144 in a generally outward direction, thereby causing hooks 142to rotate generally inwards. After obturator 86 is fully inserted intoballoon tip cannula 82, the operator releases levers 144, therebyallowing arms 140 to return their starting position. In the startingposition, hooks 142 engage recesses 112 to retain latching adapter 132and obturator 86 in position. In addition, when the assembled structureis fully inserted, obturator tip 134 extends beyond the distal end oftube 88.

Cap 130 includes a pair of grooves 146 configured and adapted forslidably receiving arms 140. It is preferred that cap 130 be configuredfor ergonomic efficiency whereby the operator can use cap 150 with aminimum of effort or discomfort.

In certain preferred embodiments, the cap 130, latching adapter 132 andobturator body 128 may be combined in a unitary structure. The obturatorbody 128 may be provided with a proximal end without latching engagementwith the adapter flange 106.

A method of using balloon tip cannula assembly 80 is disclosed. Anincision is made in the skin of the patient in the area of interest.Using the assembled balloon tip cannula assembly 80, the surgeonadvances obturator tip 134 and the distal end of balloon tip cannulaassembly 80 into the incision, thereby positioning balloon tip cannulaassembly 80 into the area of interest.

Once balloon tip cannula assembly 80 is positioned, inflation fluid isapplied through valve port 114 and valve port 108 thereby communicatingthe inflation pressure to proximal lumen port 92. Since proximal anddistal lumen ports 92, 94 are in direct fluidic communication with eachother through inflation lumen 96, inflation fluid is transferred todistal lumen port 94 and therefore to balloon anchor 98. As inflationfluid is applied to balloon anchor 98, it expands to reach itspredetermined shape. After the anchor balloon 98 is expanded, it abutsthe underside of the patient's skin to hold balloon tip cannula assembly80 in position. Preferably, balloon anchor 98 has a shape for anchoringthe balloon tip cannula assembly 80, such as the toroidal shape shownand is of sufficient size to hold cannula 80 in a desired position. Itis contemplated that the balloon anchor may have any other shape.

After balloon tip cannula assembly 80 is located through the incisionand balloon anchor 98 expanded, skin seal 100 is advanced distally alongcannula tube 88 until it is in an abutting relationship with the outersurface of the patient's body such that foam collar 102 is compressedand means for securing 104 the skin seal 100 are actuated to lock skinseal against cannula tube 88.

Once balloon tip cannula assembly 80 is anchored in position, levers 144are rotated outwards causing arms 140 to rotate inwards, therebydisengaging hooks 142 from recesses 112. After hooks 142 are disengagedfrom recesses 112, obturator 86 is retracted from balloon tip cannula 82while the surgeon holds balloon tip cannula 82 in position, therebyseparating the components. After obturator 86 is completely removed,other surgical structures may be installed in balloon tip cannula 82 toaccess the surgical site. Examples of such surgical instruments include,but are not limited to, endoscopes, graspers, shears, surgical suturingdevices, and surgical device applicators.

Upon completion of the surgical procedure, the surgeon deflates anchorballoon 98 by operating valve 110. Inflation pressure held by anchorballoon 98 exits the system through valve port 114 by reversing the flowpath for inflation. Once anchor balloon 98 is sufficiently deflated,balloon tip cannula 92 is removed from the surgical site. The siliconesleeve over the anchor balloon 98 resiliently applies pressure againstthe balloon, tending to deflate the balloon as the valve is opened.After removal, the incision may be sutured closed, or other surgicalstructures may be used at the incision site for additional surgicalprocedures.

Referring now to FIGS. 5 and 6, and as noted above, balloon dissectorassembly 10 and balloon tip cannula 80 can be used separately asindividual instruments in the manner described hereinabove orpreferably, and more advantageously, can be combined together to form acombined balloon dissector with balloon tip cannula 200. This allows thesurgeon to eliminate operational steps when creating an anatomical spacewithin a body. Balloon dissector with balloon tip cannula 200 includescomponents of balloon dissector above and balloon tip cannula above.Each of these instruments are designed so as to be easily combined intoa single instrument.

Referring now to FIGS. 5 and 6, the combined assembly 200 has theballoon dissector 12 and obturator assembly 26 inserted throughretaining ring 126 and duckbill valve 122 of the balloon tip cannula 82such that dissection balloon 14 and dissector tube 18 are advancedthrough cannula tube 88 of balloon tip cannula 82. The balloon dissector12 desirably has a latching adapter 34 that engages recesses 112 in anadapter body 106 of balloon tip cannula 82 to securely lock balloondissector 12 to balloon tip cannula 82. However, in other embodiments,no connecting structure is provided. Once assembled, the combinedballoon dissector with balloon tip cannula 200 is ready to be used tocreate an anatomical space within a body cavity within a patient's bodyand provide a secured access port for receipt of surgical instruments.

In use, an initial incision is made through the abdominal wall of apatient's body. The combined balloon dissector with balloon tip cannula200 is positioned such that dissection balloon 14, supported byobturator assembly 26, is inserted through the incision. The combineddevice is advanced through the incision until dissection balloon 14 isat a desired location. At this point, obturator assembly 26 may beremoved and a endoscope inserted therein.

Once in a proper position, a source of inflation fluid is connected tovalve port 52 of dissector inflation valve 50 and inflation fluid isforced through connecting port 48 and the lumen 23 defined by the innersurface of tube 18 and the outer surface of obturator 26. The inflationpressure forces dissector balloon 14 to start to expand which forcesperforations 21 of sleeve cover 60 (FIG. 2) to separate to therebyrelease the balloon. As noted above, the balloon is typically in arolled up configuration and as it unfurls it unrolls or unfoldslaterally and expands vertically relative to the plane of the balloon toseparate tissue layers along natural tissue planes to form an anatomicalspace for a surgical procedure.

Once the tissue has been dissected and the anatomical space formed,dissection balloon 14 can be deflated by opening dissector inflationvalve 50 to release the inflation pressure or by removing obturatorassembly 26 thereby opening the adapter orifice 46 to the inflationlumen 23, which is defined between obturator 26 and the inner surface ofdissector tube 18. Once balloon 14 has been deflated, the balloondissector assembly 10 is disconnected from the balloon tip cannula 82 bydepressing levers 40 thereby releasing hooks 38 on latching adaptor 34from recesses 112 in adapter body 106. The balloon tip cannula 82 isslid down the tube 18 of balloon dissector assembly 10 and the balloontip cannula 82 is advanced through the incision to position balloonanchor 98 within the abdominal wall. A source of inflation fluid isconnected to valve 110 to inflate balloon anchor 98. Once balloon anchor98 has been inflated, the user applies a slight proximal tension on thecombined device so as to draw anchor balloon against the inner surfaceof the abdominal wall. The skin seal 100 (FIG. 4) is slid distally alongcannula tube 88 to compress foam 102 against an outer surface of abdomenand, upon actuating the securing means 104 of skin seal 100, cannula 82is securely locked to the abdominal wall, sealing the incision againstescape of insufflation fluid.

The balloon dissector assembly 10 is then removed from balloon tipcannula 82. Once balloon dissector has been removed, duck bill valve 122is in a closed position to form a seal in the proximal end of balloontip cannula 82. Thereafter, a source of insufflation fluid is connectedto insufflation port 120 and fluid forced through balloon tip cannula 82into the body to insufflate and expand the space. Once a space has beencreated with the insufflation fluid, additional instruments includingendoscopes, graspers, tackers, staplers, etc. may be inserted throughballoon tip cannula to perform an operation such as, for example, ahernia repair procedure, within a patient.

In alternative embodiments, the obturator assembly 26 may be removed,either before or after the balloon dissector assembly 10 is introducedinto the body, and an endoscope may be inserted into the dissector tube18 prior to or after inflation of the dissection balloon.

Once a procedure has been completed, insufflation fluid is withdrawnfrom the body through insufflation port 120 and anchor inflation valve110 is opened to allow the inflation fluid to exit from anchor balloon98. The silicone sleeve of the anchor balloon 98 provides pressuretending to deflate the anchor balloon 98. Balloon tip cannula 82 is thenremoved through the incision and the incision and the incision is closedin a normal manner.

Prior art dissection methods generally include inserting a first device,typically a type of dissector, into the patient through an incision atthe surgical site whereupon the surgical personnel will dissect theseparated tissues. Then a second device, typically a trocar cannula isused to insufflate, maintaining a working space.

Using a combination device including a balloon tip cannula 82 and aballoon dissector 12 minimizes the number of procedural steps requiredto dissect and insufflate. Furthermore, the balloon tip cannula 82includes a skin seal and balloon anchor for anchoring the balloon tipcannula 82 and sealing the incision. Ports for inflating the dissectionballoon 14 and balloon anchor 98 are provided. The balloon anchor 98 iseasily deflated, as the sleeve 158 biases the balloon 98 towardsdeflation. Separate deflation mechanisms are not required, but may beprovided. The combined device 200 includes a passage for receiving anendoscope so that dissection may be observed.

Referring to FIGS. 7 and 8, an alternate embodiment of a balloondissector and cannula assembly 210 is shown and has a balloon dissectorassembly 212 and a balloon tip cannula assembly 213. Balloon dissectorassembly 212 has an elongated tube 218 having a distal end and aproximal end and defining a passage 220. A dissection balloon 214 a isaffixed to the distal end of tube 218. Dissection balloon 214 a forms achamber that communicates with passage 220. Dissection balloon 214 a isround and expands to a shape that follows the path of least resistancein tissue. The dissection balloon 214 a may have other shapes, such asoblong, kidney shaped, etc.

Referring to FIGS. 8 and 9, a dissector housing 230 is formed on theproximal end of tube 218. The dissector housing 230 has an orifice at aproximal end and includes a seal. Dissector housing 230 may be formed oftwo parts to support the seal. Dissector housing 230 defines aninflation port 222 dimensioned for receiving a one-way inflation valve.The inflation valve and inflation port 222 communicate with dissectionballoon 214 a through tube 218.

An obturator 226 having a distal tip 266 is received through the orificein the dissector housing 230, through passage 220 in tube 218, and intothe chamber of dissection balloon 214 a. The outer surface of obturator226 and the inner surface of tube 218 form an inflation lumen betweeninflation port 222 and dissection balloon 214 a. The proximal end ofobturator 226 has a cap 229 which carries resilient latches 231connected to buttons 233. When obturator 226 is received in dissectorhousing 230 and advanced into tube 218, distal tip 266 engagesdissection balloon 214 a and supports it in a collapsed, elongated shape(not shown). The latches engage recesses on dissector housing 230.Additional latches 232, connected to buttons 234, are provided ondissector housing 230 for interconnecting dissector housing 230 tocannula housing 306 of balloon tip cannula assembly 213.

In order to inflate dissection balloon 214 a, a source of inflationpressure is releasably attached to inflation port 222 and pressurizedfluid is introduced through inflation port 222 and communicated throughinflation tube 218 to dissection balloon 214 a.

Referring to FIGS. 8 and 10, balloon tip cannula assembly 213 has acannula 300 which is open at its proximal and distal ends to define anaccess lumen 302 for receipt of surgical instruments therethrough. Aninflatable balloon anchor 304, having a generally toroidal shape, isdisposed in the distal region of cannula 300. As with prior embodiments,the balloon anchor 304 is formed by dipping the cannula into a urethanecoating and then using thermal welding to attach a urethane membrane tothe coated cannula. The membrane is then coated with RTV and heat shrinktube collars reinforce the sleeve at the welded ends. Alternatively, theballoon anchor 304 may be attached as discussed above in connection withFIGS. 4A-4D.

A cannula housing 306 is attached to cannula 300 at a proximal end ofcannula 300. Cannula housing 306 has an orifice that communicates withaccess lumen 302. A valve port 308 is provided in a surface of cannulahousing 306. Valve port 308 is dimensioned to receive a check valve in asubstantially fluid-tight sealing manner. An inflation lumen 311 isdefined between the inner surface and the outer surface of cannula 300and extends to balloon anchor 304. The check valve communicates withballoon anchor 304, through the lumen in the wall of the cannula.

In order to inflate balloon anchor 304, a source of inflation pressureis releasably attached to the check valve, introducing pressurized fluidthrough valve port 308 to balloon anchor 304, which causes balloonanchor 304 to expand.

An insufflation port 314 is also provided on cannula housing 306, and influid communication with the interior of cannula housing 306 and cannula300, to provide insufflation fluid to the interior of a patient's body.

A seal assembly is provided in the cannula housing 306 for sealing theinterior of cannula 300 during insufflation. The seal assembly generallyincludes a seal for sealing around instruments inserted into cannula 300and a seal for sealing cannula 300 in the absence of any instrumentsinserted into cannula 300. These seals may be the seals discussed abovein connection with FIG. 3.

A skin seal 316 is slidably mounted on the outside surface of cannula300. Skin seal 316 includes a compressible foam collar 318 and a clamp320 for securing the skin seal in a desired longitudinal position alongthe cannula. The skin seal 316 may be as discussed above in connectionwith FIG. 4.

Referring to FIG. 10, an obturator 323 having a proximal cap 324 and adistal end 325 is inserted in the orifice of cannula housing 306, andadvanced through lumen 302 of cannula 300, so that distal end 325extends out of the distal end of cannula 300. Cannula housing 306 hasrecesses 329 for receiving latches 327 on proximal cap 324 of obturator323. Proximal cap 324 also carries buttons 331 for disengaging thelatches. To assemble the balloon dissector assembly 212 and balloon tipcannula assembly 213, obturator 323 is removed from cannula 300. Balloondissector assembly 212 is inserted into the orifice of cannula housing306 and advanced through lumen 302 of cannula 300 so that latches 232 ondissector housing 230 are engaged with cannula housing 306,inter-connecting the assemblies.

The balloon dissector assembly 212 is used for dissecting tissue alongnatural tissue planes in general, laparoscopic, vascular, endoscopic,plastic or reconstructive surgery. A suitably sized incision is made inthe patient's skin. Next, the assembled balloon dissector and cannulaassembly 210 is inserted into the incision, using the obturator 226 totunnel a passage beyond the point of incision.

Inflation pressure is supplied through inflation port 222 from asuitable outside source and is communicated to dissection balloon 214 a.As pressure is applied, dissection balloon 214 a expands. The expansionof dissection balloon dissects surrounding tissue along natural tissueplanes. Once the desired space is created, dissection balloon 214 a isdeflated by removal of obturator 226 which allows the inflation pressureto be relieved through the orifice in the dissector housing 230.

In an alternative method, obturator 226 is removed from tube 218 andreplaced with an endoscope. Then, balloon dissector assembly 212 isinserted into the skin incision and dissector balloon 214 a is inflatedas discussed above. The scope is used for viewing the dissected spaceand for viewing during dissection. The endoscope may be inserted intotube 218 before or after dissection.

After dissection balloon 214 a is deflated, cannula housing 306 isunlatched from dissector housing 230 by pressing buttons 234 ondissector housing 230. Cannula 300 is advanced along balloon dissectortube 218 and positioned within the incision so that balloon anchor 304is located inside the body cavity. Inflation fluid is supplied throughvalve port 308 thereby communicating the inflation fluid to balloonanchor 304 at the distal end of cannula 300, expanding balloon anchor304. After anchor balloon 304 is expanded, it is brought into engagementwith the underside of the patient's abdominal wall.

Skin seal 316 is moved into position against the surface of the patientabdominal wall and secured using the clamp. Skin seal 316 forms apressure barrier, thereby minimizing the loss of insufflation pressurethrough the opening in the patient's abdominal wall and, in combinationwith anchor balloon 304, secures balloon tip cannula 300 to thepatient's body.

Balloon dissector assembly 212 is removed from cannula 300 and surgicalinstruments are introduced to the surgical site through cannula 300.Examples of such surgical instruments include, but are not limited to,endoscopes, surgical suturing devices, and surgical manipulationdevices, etc.

Upon completion of the surgical procedure, the surgeon deflates anchorballoon 304 by releasing the check valve attached to valve port 308.Once anchor balloon 304 is sufficiently deflated, cannula 300 is removedfrom the incision.

The balloon dissector assembly 212 may be provided with a second type ofdissection balloon which is a laterally extending oval balloon. The ovalballoon and/or round balloon may comprise an elastic or inelasticmaterial. The elastic material will tend to follow the path of leastresistance in the patient's body, whereas the inelastic balloon tends toexpand to a predetermined shape. The selection of the type of balloon isleft up to the surgeon.

The oval dissection balloon 214 b desirably has an initial collapsedconfiguration, with the lateral margins of balloon 214 b rolled inwardlytoward obturator 226 of balloon dissector assembly 212, similar to therolled configuration discussed above in connection with FIG. 2A.Obturator 226 desirably has two recessed flats 340, one on each of thelateral sides of obturator 226, for accommodating the rolled margins ofballoon 214 b (FIG. 9). A sleeve (not shown) is provided arounddissection balloon 214 b to retain dissection balloon 214 b in acollapsed condition during insertion into the body and prior toinflation. The sleeve comprises a sheet of polymeric material that maybe attached to the material of the balloon 214 b, as discussed above.The sleeve includes a longitudinal weakened perforated region such that,upon inflation of dissection balloon 214 b, the sleeve separates alongthe perforations and releases dissection balloon 214 b. As the balloonis inflated, the balloon unrolls or unfolds in a lateral direction withrespect to the tube 218.

Although the illustrative embodiments of the present disclosure havebeen described herein with reference to the accompanying drawings, it isto be understood that the disclosure is not limited to those preciseembodiments, and that various other changes and modifications may beaffected therein by one skilled in the art without departing from thescope or spirit of the disclosure. All such changes and modificationsare intended to be included within the scope of the disclosure.

1. A surgical instrument comprising: a balloon tip cannula assembly,including: a cannula housing, a cannula tube extending distally from thecannula housing, the cannula housing having a balloon anchor at a distalend of the cannula tube, and a skin seal movable along the cannula tube;a balloon dissector assembly configured to be received through aproximal opening of the balloon tip cannula assembly, the balloondissector assembly being engageable and disengageable from the balloontip cannula assembly, the balloon dissector assembly including: adissector housing, a dissector tube including a proximal end, thedissector tube extending distally from the dissector housing, and adissection balloon mounted on a distal end of the dissector tube; anobturator having a distal tip configured to be received through proximalopenings of the balloon tip cannula assembly and the balloon dissector,the distal tip of the obturator supporting and contacting the dissectionballoon, the obturator being separable and removable from the balloontip cannula assembly prior to and after inflation of the dissectionballoon; and one of the dissector housing and cannula housing includinga latching structure having a latch, and the other of the dissectorhousing and cannula housing having a recess for receipt of the latch ofthe latching structure, wherein the cannula housing and the dissectorhousing are releasably coupled to one another.
 2. The surgicalinstrument as recited in claim 1, wherein the latching structureincludes at least one movable arm.
 3. The surgical instrument as recitedin claim 2, wherein the at least one movable arm include a hookengageable with the recess.
 4. The surgical instrument as recited inclaim 1, further comprising: an adapter assembly configured forattachment to the proximal end of the dissector tube, the adapterassembly including: a shroud, the shroud removably attachable to thecannula housing, the shroud being configured and adapted to surround theproximal end of the dissector tube; a latching adapter; and an end cap,wherein any of the end cap, latching adapter, and shroud are combinable,and wherein any of the end cap, latching adapter, and shroud areremovable from one another.
 5. The surgical instrument as recited inclaim 1, further comprising an end cap removably attachable to thedissector housing.
 6. The surgical instrument as recited in claim 1,further comprising a sleeve surrounding at least a portion of theballoon anchor, the sleeve tending to bias the balloon anchor towardsdeflection, the cannula housing having a valve in communication with theballoon anchor.
 7. The surgical instrument as recited in claim 6,wherein the anchoring balloon is formed of urethane material.
 8. Thesurgical instrument as recited in claim 6, further comprising a ringpositioned about each opposed end of the sleeve.
 9. The surgicalinstrument as recited in claim 8, wherein each ring is formed of a heatshrinkable material.
 10. The surgical instrument as recited in claim 1,wherein the balloon dissector assembly and the obturator are separatelyattachable to the balloon tip cannula assembly.
 11. The surgicalinstrument of claim 1, wherein the obturator supports and contacts thedissection balloon in a collapsed state.
 12. A surgical instrumentcomprising: a balloon tip cannula assembly, including: a cannula housinghaving a cannula tube extending therefrom, the cannula tube having aballoon anchor disposed at one end thereof, and a skin seal movablealong the cannula tube; a balloon dissector assembly configured to bereceived through a proximal opening of the balloon tip cannula assembly,the balloon dissector assembly being engageable and disengageable fromthe balloon tip cannula assembly, the balloon dissector assemblyincluding: a dissector housing; a dissector tube including a proximalend, the dissector tube extending distally from the dissector housing,and a dissection balloon mounted on one end of the dissector tube; anobturator configured to be received through proximal openings of theballoon tip cannula assembly and the balloon dissector assembly, atleast a portion of the obturator supporting and contacting thedissection balloon, the obturator being engageable and disengageablefrom the balloon tip cannula assembly prior to and after inflation ofthe dissection balloon; and an adapter assembly configured forattachment to the proximal end of the dissector tube, the adapterassembly including: a shroud, the shroud removably attachable to thecannula housing, the shroud being configured and adapted to surround theproximal end of the dissector tube, a latching adapter, and an end cap,wherein any of the end cap, latching adapter, and shroud are combinable,and wherein any of the end cap, latching adapter, and shroud areremovable from one another, wherein one of the dissector housing andcannula housing including a latching structure having a latch, and theother of the dissector housing and cannula housing having a recess forreceipt of the latch of the latching structure, wherein the cannulahousing and the dissector housing are releasably coupled to one another.13. The surgical instrument of claim 12, wherein the obturator supportsthe dissection balloon in a collapsed state.
 14. The surgical instrumentof claim 12, wherein a distal portion of the obturator supports andcontacts the dissection balloon.